Phase 2 Study of Duvelisib in Previously Treated Patients With Chronic Lymphocytic Leukemia / Small Lymphocytic Lymphoma
This is a multi-center, single-arm, open-label, Phase 2 study of duvelisib, an orally bioavailable dual inhibitor of PI3K-δ,γ, in patients with CLL / SLL who have previously been treated with ibrutinib or another Bruton's Tyrosine Kinase Inhibitor (BTKi) and relapsed or were refractory to such therapy or discontinued such therapy due to toxicity.
- ≥ 18 years of age.
- Diagnosis of CLL or SLL.
- Received at least one prior anti-cancer therapy for CLL or SLL.
- Previous exposure to BTKi and meet at least one of the criteria below:
- Progressive disease (PD) while receiving or within 6 months after completing BTKi therapy.
- Discontinued a BTKi therapy due to BTKi treatment- related intolerance.
- Measurable disease with a lymph node or tumor mass > 1.5 cm in at least one dimension.
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.
- Resolution of toxicities due to prior BTKi therapy to acceptable level.
- Willingness of male and female patients to use medically acceptable methods of birth control.
- Willing and able to participate in all required study evaluations and procedures.
- Richter's transformation or prolymphocytic leukemia
- Uncontrolled autoimmune hemolytic anemia or thrombocytopenia
- Received prior transplant
- Experienced PD or serious adverse events on a prior phosphoinositide-3-kinase (PI3K) inhibitor
- Known central nervous system involvement by CLL/SLL
Locations & Contacts
Trial Phase & Type
Secondary IDs NCI-2018-02003
Clinicaltrials.gov ID NCT03370185